Diabetes & Metabolism Journal (original) (raw)

Table 1 The patients' demographics and baseline characteristics (full analysis set)

Values are presented as number (%) or mean±standard deviation. Data shown are for Visit 1 unless otherwise specified.

BMI, body mass index; HbA1c, glycated hemoglobin; NGSP, National Glycohemoglobin Standardization Program; FPG, fasting plasma glucose; FSI, fasting serum insulin; eGFR, estimated glomerular filtration rate.

aFisher exact test, bTwo-sample t-test.

Table 2 Changes in secondary efficacy variables from baseline to end of treatment (full analysis set)

SD, standard deviation; CI, confidence interval; HOMA-IR, homeostatic model assessment of insulin resistance; HOMA-β, homeostatic model assessment of β-cell function; FSI, fasting serum insulin.

aAnalysis of covariance model including baseline value as a covariate.

Table 3 Changes in clinical and laboratory parameters from baseline to end of treatment (safety analysis set)

Values are presented as mean±standard deviation.

SBP, systolic blood pressure; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; HDL-C, high density lipoprotein cholesterol; LDL-C, low density lipoprotein cholesterol.

aTwo-sample t-test.

Table 4 Change in hematology and other laboratory variables from baseline to end of treatment (safety analysis set)

Values are presented as number (%).

TEAE, treatment-emergent adverse event.

aTotal number of events, where patients may have experienced two or more events, bPatients presenting with two or more TEAEs were counted only once, cThe most severe TEAE was counted if the patient presented with two or more TEAEs with varying severity.

Table 5 Change in hematology and other laboratory variables from baseline to end of treatment (safety analysis set)

Values are presented as mean±standard deviation.

BUN, blood urea nitrogen; Cr, creatinine; RBC, red blood cell; NAG, β-N-acetyl-D-glucosaminidase; AST, aspartate transaminase; ALT, alanine transaminase; LDH, lactate dehydrogenase; ALP, alkaline phosphatase; γ-GTP, γ-glutamyl transpeptidase.

aTwo-sample t-test.